Children's cancer cures 'put at risk by EU regulations'

Children with cancer will be denied “cutting edge” treatments due to EU
bureaucracy, doctors have warned.

They called for substantial changes to the rules on clinical trials, saying the EU Clinical Trials Directive was stifling research into therapies that could mean more children survive to adulthood, and treatments with less serious long-term side effects.

Every year 1,500 children in Britain are diagnosed with cancer. In the early 1970s, little more a quarter were expected to survive at least five years, but now four in five will overcome it, according to a report published today in the journal Annals of Oncology.

The report says this is due to better diagnosis and what the authors describe as “revolutionary changes in treatment”.

British researchers have frequently paved the way in new treatments, and British children have been among the first to benefit. But the authors warn that the EU directive, which is intended to harmonise trials methods and set minimum standards, is putting that at risk. Kathy Pritchard-Jones, professor of paediatric oncology at the Institute of Child Health, University College London, said trials had become harder to open, especially when they ran in different countries.

Universities and hospitals were snowed under with paperwork because they had to report all serious side effects immediately, even for well-known drugs that were just being tested in a new clinical setting, she said.

“It’s all incredibly bureaucratic. The whole process needs to be much simpler and less expensive,” Prof Pritchard-Jones added. “If no trial is available it may not have an immediate effect on survival. However, if that situation were to persist for many years, one would predict that the rate of improvement of survival would cease and children in the UK would no longer be receiving cutting edge treatment.”

Hundreds of new drugs are being developed for adults that could help child sufferers, she said, but without trials none would be used. “If we just carry on how we are, we are not going to reach 90 per cent [long-term survival],” she warned.

Certain childhood cancers such as acute lymphoblastic leukaemia already have five-year survival rates topping 90 per cent. But for others such as neuroblastoma, a brain tumour, the chance is still little better than one in two.

Prof Pritchard-Jones said children also often had to undergo high-dose radiotherapy and chemotherapy that left them infertile or with heart or kidney problems.

Charles Stiller, the registry director of the Childhood Cancer Research Group at Oxford University, and lead author of the report, said that for some forms of cancer nine in 10 child patients were enrolled in trials, but added: “The directive is bound to drag it down. A lot of clinicians are concerned about this.” Since the directive was introduced in 2004, Britain’s global share of trials has dropped from six to two per cent. Yesterday the European Commission admitted the directive had “led to an unfavourable regulatory framework”, contributing to a 25 per cent fall in trials across the EU between 2007 and 2011.

It proposed to simplify set-up and reporting procedures to make them faster and cheaper. John Dalli, the European Commissioner for Health and Consumer Policy, said: “Patients in Europe should have access to the most innovative clinical research.”